Polyscrew Pedicle Screw System— 510(k) K150647
Substantially EquivalentNew Era Orthopedics, LLC
FDA 510(k) clearance K150647 for Polyscrew Pedicle Screw System, Substantially Equivalent on 2015-04-08. Applicant: New Era Orthopedics, LLC.
Clearance details
- Applicant
- New Era Orthopedics, LLC
- Product code
- Code MNI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hummelstown, PA, US
Adverse events under product code MNI
product code MNI- Injury
- 641
- Total
- 641
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.